Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

This study has been completed.

Sponsor:

William Beaumont Hospitals

ClinicalTrials.gov Identifier:

NCT00672100

First Posted: May 6, 2008

Last Update Posted: March 7, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.

Secondary Outcome Measures:

Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful" [ Time Frame: at 24 and 48 hours after discharge from the hospital ]

At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed.

To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses.

To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses.

To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses.

To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.

Eligibility

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Ages Eligible for Study:

18 Years to 80 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Provide written informed consent prior to participation in the study.

Is scheduled to undergo Arthroscopic Rotator Cuff Repair, defined as arthroscopically assisted repair of any of the muscles or tendons comprising the rotator cuff.

If subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery per standard of care

Be at least 18, but not more than 80 years of age

Have an ASA risk class of I, II, or III according to the American Society of Anesthesiologists (ASA).

Have the ability to read and understand the study procedures and the use of the pain scales. Must have the ability to communicate meaningfully with the Study Investigator and staff.

Be free of other physical, mental, or medical conditions, which in the opinion of the Investigator, makes study participation inadvisable.

Exclusion Criteria:

Subjects requiring daily opioids equivalent to greater than 40 mg oxycodone for over 2 weeks prior to the study.

Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.

Has known significant hypersensitivity to opioids, Ropivacaine, or the inactive ingredients (excipients) of the study medications.

Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years.

Has clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) based on medical history and examination.

Has participated in another clinical Study (investigational or marketed product within 30 days of surgery.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672100